Apparatus and method for moving sealing members of a medical apparatus between a first orientation and a second orientation

ABSTRACT

A medical apparatus includes a trocar assembly including a cannula and a trocar, wherein (1) the cannula has a lumen defined therein, (2) the trocar is positionable between a first trocar position and a second trocar position, (3) the trocar is positioned within the lumen of the cannula when the trocar is positioned at the first trocar position, and (4) the trocar is completely removed from the lumen of the cannula when the trocar is positioned at the second trocar position. The medical apparatus also includes a sleeve having a passageway extending therethrough, and a number of sealing members extending therefrom, wherein (1) the cannula is positionable between a first cannula position and a second cannula position, (2) the cannula is positioned within the passageway of the sleeve when the cannula is positioned at the first cannula position, and (3) the cannula is completely removed from the passageway of the sleeve when the cannula is positioned at the second cannula position. The medical apparatus further includes an actuator secured to the sealing members and having a chamber defined therein, the actuator further defining a port through which fluid may be advanced into or withdrawn from the chamber. A medical procedure utilizing the medical apparatus is also disclosed.

This application is a continuation-in-part of copending U.S. applicationSer. No. 08/656,430, filed May 30, 1996, now 5,752,553 which is acontinuation-in-part of copending U.S. application Ser. No. 08/608,644filed Feb. 29, 1996 now 5,766,220.

BACKGROUND OF THE INVENTION

The present invention generally relates to an apparatus and method forprotecting a port site wound in the wall of a body cavity. The presentinvention particularly relates to an apparatus and method for protectinga port site wound in the wall of a body cavity which is used with atrocar assembly.

Minimally invasive surgical techniques, such as laparoscopic surgery,typically include the use of a trocar assembly. A trocar assemblyincludes a trocar (sometimes referred to as an "obturator") positionedwithin the lumen of a cannula. The trocar and cannula are advancedthrough a body cavity wall so as to create a small hole or a port sitewound therein. The trocar is then completely removed from the lumen ofthe cannula such that the cannula's lumen provides an entrance forlaparoscopic instruments into the interior of the body cavity. The bodycavity is then insufflated with an inert gas, such as CO₂, to provideeasier access to the organs contained therein. Once the surgery iscomplete the cannula is completely removed from the port site wound torapidly desufflate the body cavity.

Surgery performed by using minimally invasive techniques is generallyassociated with lower postoperative morbidity, shorter postoperativestay, less postoperative pain, decreased cost, and quicker recovery ascompared to "open" or conventional surgical techniques.sup.(1,2,3,4).Because of the aforementioned advantages, these minimally invasivetechniques are being applied to an increasing variety of all surgicalprocedures. For example, laparoscopic procedures for the resection ofmalignancies have emerged. In particular, laparoscopic colectomy forcarcinoma of the colon has been developed, and it has been reported thatthe initial results of these procedures have advantages over operationsperformed in the traditional open manner.sup.(5,6,15). Moreover, it ishoped that the long term results of these procedures will be comparable,or better than, those performed in the traditional open manner.

However, the development of laparoscopic surgery for cancer has beenhindered because of the major concern regarding the implantation oftumor cells in the port site wound.sup.(2,3,6,7). In fact, numerous portsite recurrences have been documented in the medical literatureheretofore, and subcutaneous metastases after laparoscopic resection ofmalignant tissue is associated with a decreased survival rate forpatients who may have had a curative cancer.sup.(2,3,6,7). Specifically,the medical literature reports that the incidence of tumor cellimplantation ranges from as high as 20% to as low as 0%.sup.(8). Thestudies generating the aforementioned data utilized highly skilled andexperienced laparoscopic surgeons practicing at major universityprograms. However, in spite of utilizing highly skilled and experiencedlaparoscopic surgeons, the data indicates that the incidence of tumorcell implantation in the surgical wound is greater when employinglaparoscopic techniques as compared to when conventional surgicaltechniques are used (i.e. 0.6% implantation incidence for conventionaltechniques.sup.(9) compared to 1% incidence for laparoscopictechniques.sup.(10).

Several mechanisms may be responsible for the above discussedimplantation of tumor cells in the port site wound. For example,minimally invasive surgical techniques for treating cancer require theinsertion and removal of laparoscopic instruments or cameras through thelumen of the cannula. In addition, these surgical techniques requirethat the cannula itself be moved relative to the port site wound suchthat the cannula is advanced further into, or withdrawn from, the bodycavity.sup.(11). Moving the cannula in the above described mannerfacilitates a surgeon's ability to optimally locate instruments withinthe body cavity thereby helping to ensure the successful completion ofthe medical procedure. However, the aforementioned manipulations of thelaparoscopic instruments and cannula may result in the exposure of theport site wound to exfoliated cancer cells which creates a risk ofimplanting tumor cells in the walls of the port site wound.sup.(11,12).In particular, exfoliated cancer cells may adhere to and thuscontaminate a portion of the exterior surface of thecannula.sup.(11,12). The contaminated portion of the exterior surface ofthe cannula may then be advanced into contact with the port site woundduring insertion and removal from the port site wound.sup.(11,12). Thiscontact may dislodge the exfoliated cancer cells from the exteriorsurface of the cannula and thus cause the exfoliated cancer cells to beimplanted in the port site wound.sup.(11,12).

Furthermore, studies have shown that a physician may undergo asignificant learning curve before becoming proficient in the performanceof laparoscopic surgery, such as cancer surgery.sup.(3,13). As a result,a relatively inexperienced surgeon may have a tendency to manipulate orhandle a tumor to a greater degree during a surgical procedure than anexperienced surgeon. In addition, an inexperienced surgeon may have atendency to insert and withdraw an instrument through the lumen of thecannula a greater number of times than an experienced surgeon. The abovedescribed increased manipulation of the instrument or the tumor canresult in a greater incidence of tumor cell implantation in the portsite wound.sup.(11,12).

Regardless of how these cells contaminate the wound, once implantedtherein, viable tumor cells can cause a subcutaneous metastases or"port/extraction site recurrence" after the resection of malignanttissue. These "port/extraction site recurrences" have delayed theadvancement of laparoscopic cancer surgery.sup.(2,6,7,8,9,10,11,12).Therefore, it is desirable to provide an apparatus which will protect aport site wound from tumor cell implantation while allowing a surgeon tooptimally locate instruments within the body cavity for successfulcompletion of the medical procedure.

Furthermore, laparoscopic surgery performed for general surgery,gynecological surgery, urological surgery, or any other intra-abdominalinfection is associated with a small but real incidence of port sitewound infection.sup.(1). The infecting bacteria causing these illnessescan contaminate the port site wound in the same manner as discussedabove with regard to tumor cell contamination, and these infections canincrease a patient's morbidity and consequently the length of a patientshospital stay, thereby considerably increasing their hospital bill.

In addition, new technologies such as remote laparoscopic surgery (i.e.robotic laparoscopic surgery) are being introduced and utilized in thefield of minimally invasive surgery.sup.(14). During use of these newtechnologies the sensory feedback to the surgeon is decreased sincerobotic "arms" and "hands" (under the surgeon's control) manipulate thesurgical instruments. The decrease in the surgeon's tactile sensoryfeedback can be a disadvantage when performing laparoscopic surgery forcancer. This is true since tactile feedback helps the surgeon avoidunnecessary manipulation of a tumor which may result in the implantationof tumor cells in the wall of the port site wound.sup.(2).

Therefore, in light of the above discussion, it is apparent that anapparatus which allows unrestricted movement of the cannula relative tothe port site wound while preventing port site wound tumor cellimplantation and reducing the incidence of port site wound infection, isdesirable. The present invention provides such an apparatus in the formof a sleeve or a cannula which protects the port site wound. Oneadvantage the present invention has over the prior art is that it can beretrofit to existing trocar assembly technology. More specifically, thesleeve of the present invention can be used with trocar assemblies whichare currently commercially available to laparoscopic surgeons. Anotheradvantage the present invention has over the prior art is that it allowsthe cannula to be advanced into and withdrawn from the port site woundwhile still protecting the port site wound from contamination by tumoror other types of cells. Moreover, once attached, the describedinvention adds only a minimal amount of bulk to the diameter of thetrocar assembly.

TABLE OF REFERENCES CITED IN THE BACKGROUND

1. Lord et al., Dis. Col. Rect. 39(2):148 (1996)

2. Berman, Important Advances in Oncology 1996, Laparoscopic Resectionfor Colon Cancer: Cause for Pause, Vincent DeVita Ed., p. 231

3. Falk et al., Dis. Col. Rect. 36:28 (1993)

4. Liberman et al., Surg. Endo. 10:15 (1996)

5. Reiver et al., Dis. Col. Rect. 37:22 (Podium Abstract 1994)

6. Regier, Gen. Surg. Lap. News 8:1 (1995)

7. Greene, Semin. Lap. Surg. 2(3):153 (1995)

8. Kazemier, Surg. Endo. 9:216 (1995)

9. Reilly et al., Dis. Col. Rect. 39(2):200 (1996)

10. Jacquet et al., Dis. Col. Rect. 38(10):140 (1995)

11. Reymond et al., Surg. Endo. 11:902 (1997)

12. Allardyce et al., Dis. Col. Rect. 40(8):939 (1997)

13. Caushaj et al., Dis. Col. Rect. 37(4):21 (Podium Abstract 1994)

14. Med. Simula. Train., 1(2):7, 12-13, 20-28 (1996)

15. Fleshman et al., Dis. Col. Rect. 39(1):15 (1996)

SUMMARY OF THE INVENTION

In accordance with one embodiment of the present invention, there isprovided a medical apparatus which includes a trocar assembly includinga cannula and a trocar, wherein (1) the cannula has a lumen definedtherein, (2) the trocar is positionable between a first trocar positionand a second trocar position, (3) the trocar is positioned within thelumen of the cannula when the trocar is positioned at the first trocarposition, and (4) the trocar is completely removed from the lumen of thecannula when the trocar is positioned at the second trocar position. Themedical apparatus also includes a sleeve having a passageway extendingtherethrough, and a number of sealing members extending therefrom,wherein (1) the cannula is positionable between a first cannula positionand a second cannula position, (2) the cannula is positioned within thepassageway of the sleeve when the cannula is positioned at the firstcannula position, and (3) the cannula is completely removed from thepassageway of the sleeve when the cannula is positioned at the secondcannula position. The medical apparatus further includes an actuatorsecured to the sealing members and having a chamber defined therein, theactuator further defining a port through which fluid may be advancedinto or withdrawn from the chamber.

Pursuant to another embodiment of the present invention, there isprovided a medical apparatus which includes a sleeve having a number ofsealing members connected thereto and a passageway extendingtherethrough. The sealing members are movable between (1) a firstorientation in which the sealing members are positioned to facilitateadvancement of the sleeve into an opening defined in a wall of a bodycavity, and (2) a second orientation in which the sealing members arepositioned to prevent fluid communication between an area inside of thebody cavity and an area outside of the body cavity through a spacedefined between the opening in the wall of the body cavity and thesleeve. The medical apparatus also includes a trocar assemblypositionable within the passageway of the sleeve, the trocar assemblyincluding a cannula and a trocar, wherein (1) the cannula is completelyremovable from the passageway of the sleeve, (2) the cannula has a lumendefined therein, and (3) the trocar is completely removable from thelumen of the cannula. The medical apparatus further includes an actuatorsecured to the sealing members and having a chamber defined therein, theactuator further defining a port through which fluid may be advancedinto or withdrawn from the chamber.

According to yet another embodiment of the present invention, there isprovided a medical procedure which includes the following steps (1)creating an opening in a wall of a body cavity, (2) advancing a medicalapparatus through the opening and into the body cavity, the medicalapparatus including (a) a sleeve having a number of sealing membersconnected thereto and a passageway extending therethrough, (b) a trocarassembly positioned within the passageway of the sleeve, the trocarassembly including a cannula and a trocar, wherein the cannula iscompletely removable from the passageway of the sleeve, the cannula hasa lumen defined therein, and the trocar is completely removable from thelumen of the cannula, and (c) an actuator having a chamber definedtherein, the actuator further defining a port through which fluid may beadvanced into or withdrawn from the chamber, (3) evacuating fluid fromthe chamber of the actuator so that the sealing members are positionedsubstantially perpendicular to the passageway, and (4) positioning thesealing members to contact an interior surface of the body cavity afterthe fluid evacuation step.

It is therefore an object of the present invention to provide a new anduseful medical apparatus.

It is another object of the present invention to provide an improvedmedical apparatus.

It is still another object of the present invention to provide a new anduseful medical apparatus for protecting a port site wound from tumorcell implantation or contamination with an infectious agent.

It is another object of the present invention to provide an improvedmedical apparatus for protecting a port site wound from tumor cellimplantation or contamination with an infectious agent.

It is moreover an object of the present invention to provide a new anduseful medical procedure for performing minimally invasive surgery.

It is still another object of the present invention to provide animproved medical procedure for performing minimally invasive surgery.

It is still another object of the present invention to provide a new anduseful apparatus for manipulating sealing members of an apparatus whichprotects a port site wound.

It is yet another object of the present invention to provide an improvedapparatus for manipulating sealing members of an apparatus whichprotects a port site wound.

It is also an object of the present invention to provide a new anduseful method for manipulating sealing members of an apparatus whichprotects a port site wound.

It is still another object of the present invention to provide animproved method for manipulating sealing members of an apparatus whichprotects a port site wound.

It is also an object of the present invention to provide a medicalapparatus for protecting a port site wound having a sleeve which can beused with trocar assemblies which are currently commercially availableto laparoscopic surgeons.

It is yet another object of the present invention to provide a medicalapparatus having a cannula which includes a plurality of sealing membersfor protecting a port site wound.

It is still another object of the present invention to provide a medicalapparatus for protecting a port site wound which adds only a minimalamount of bulk to the diameter of a trocar assembly.

It is yet another object of the present invention to provide a medicalapparatus which protects against the loss of the pneumoperitoneum.

It is still another object of the present invention to provide a medicalapparatus which is securely positioned in the port site wound.

It is yet another object of the present invention to provide a medicalapparatus which continuously protects the port site wound from tumorcell implantation, or contamination with an infectious agent, during themovement of a cannula relative to the port site wound.

The above and other objects, features, and advantages of the presentinvention will become apparent from the following description andattached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary side elevational view of a medical apparatusinserted through a body cavity wall which incorporates the features ofthe present invention therein, with the body cavity wall shown incross-section for clarity of description;

FIG. 2 is an enlarged end elevational view of the medical apparatustaken along line 2--2 of FIG. 1, with the trocar and body cavity wallshown removed for clarity of description;

FIG. 3 is a reduced fragmentary side elevational view of the medicalapparatus taken along line 3--3 of FIG. 2;

FIG. 4 is an enlarged cross sectional view of the medical apparatus ofFIG. 1, with the guide member shown in a first position and the sealingmembers shown in a first orientation;

FIG. 5 is an enlarged cross sectional view of the medical apparatus ofFIG. 1, with the guide member shown in a second position and the sealingmembers shown in a second orientation;

FIG. 6 is a view similar to FIG. 2, however the medical apparatus isshown reduced, and the sealing members are shown in the secondorientation;

FIG. 7 is a fragmentary side elevational view of the medical apparatustaken along line 7--7 of FIG. 6;

FIG. 8 is a fragmentary side elevational view of a medical apparatussimilar to the one shown in FIG. 1, but this medical apparatus includesa strippable liner thereon (the handles are shown removed for clarity ofdescription);

FIG. 9 is a fragmentary side elevational view of the medical apparatusshown in FIG. 8, with the strippable liner peeled off, and the sleevepeeled down and attached to an exterior surface of a body cavity wall;

FIG. 10 is a fragmentary side elevational view of a medical apparatussimilar to the one shown in FIG. 1, but this apparatus includes a lockmember;

FIG. 11 is an elevational view of the lock member taken along line11--11 of FIG. 10, with the body wall and the rest of the medicalapparatus shown removed for clarity of description;

FIG. 12 is a side elevational view of the lock member of FIG. 11, withthe first and second portions of the lock member shown separated;

FIG. 13 is a side elevational view of the first portion of the lockmember taken along line 13--13 of FIG. 12;

FIG. 14 is an enlarged fragmentary side elevational view of the firstportion of the lock member taken along line 14--14 of FIG. 13;

FIG. 15 is a side elevational view of another sleeve which incorporatesthe features of the present invention;

FIG. 16 is a side elevational view of the sealing member of the sleevetaken along line 16--16 of FIG. 15 with a biologically active compounddisposed thereon (note that the biologically active compound is showndisposed on only a portion of the sealing member for clarity ofdescription);

FIG. 17 is a fragmentary side elevational view of the sleeve taken alongline 17--17 of FIG. 15;

FIG. 18 is an enlarged fragmentary cross sectional view of the sealingmember taken along line 18--18 of FIG. 15;

FIG. 19 is a fragmentary side elevational view of a medical apparatussimilar to the one shown in FIG. 1, but with a vacuum source and an airsupply of the medical apparatus being shown in fluid communication withan actuator of the medical apparatus;

FIG. 20 is an enlarged elevational view of the medical apparatus takenalong line 20--20 of FIG. 19, with the body cavity wall, trocar and hoseremoved for clarity of description;

FIG. 21 is an enlarged fragmentary cross sectional view of the medicalapparatus of FIG. 19, with the sealing members shown in the firstorientation;

FIG. 22 is a view similar to FIG. 21 but showing the sealing memberspositioned in the second orientation;

FIG. 23a is an enlarged view of a portion of FIG. 21 which is encircledand indicated as FIG. 23a, which shows the actuator in greater detail;

FIG. 23b is an enlarged view of a portion of FIG. 22 which is encircledand indicated as FIG. 23b, which shows the flexible cover folded andpositioned within the chamber of the actuator;

FIG. 24 is a fragmentary cross sectional view of a sleeve, a sealingmember (positioned in the first orientation), a support member, and anactuator which are similar to the ones shown in FIGS. 15 and 16, butwith the sealing member and the support member having corrugated areasdefined thereon;

FIG. 25 is a fragmentary cross sectional view of the sleeve, the sealingmember, the support member, and the actuator shown in FIG. 24, but withthe actuator positioned such that the sealing member assumes the secondorientation;

FIG. 26 is an enlarged view of a portion of FIG. 28 which is encircledand indicated as FIG. 26;

FIG. 27 is a side elevational view of the medical apparatus of FIG. 1inserted through the body cavity wall but showing a valve assemblyattached to an end of the cannula, the sealing members are shown in thesecond orientation and the trocar is shown completely removed from thecannula (note that the actuator is not shown, and the body cavity walland the sleeve are shown in cross-section for clarity of description);

FIG. 28 is a view similar to FIG. 27, however a medical instrument isshown inserted through the lumen of the cannula and the cannula isadvanced to a length L₁ into the body cavity;

FIG. 29 is a view similar to FIG. 28, however the cannula is shownadvanced to a length L₂ into the body cavity;

FIG. 30 is a view similar to FIG. 29, however the cannula is shownwithdrawn from the body cavity such that an end of the cannula isadjacent to an end of the sleeve;

FIG. 31 is a view similar to FIG. 27, however the cannula is showncompletely removed from the passageway of the sleeve;

FIG. 32 is a view similar to FIG. 29, however the medical apparatus isshown not equipped with the sleeve;

FIG. 33 is a cross-sectional view of the body cavity wall after removingthe medical apparatus shown in FIG. 32 therefrom;

FIG. 34 is a fragmentary side elevational view of an alternativeembodiment of the cannula of the trocar assembly of FIG. 1, with thecannula having a plurality of fluid bladder sealing members spaced apartfrom each other along the longitudinal axis of the cannula (note thatthe body cavity wall is shown in cross section for clarity ofdescription);

FIG. 35 is a view similar to FIG. 34, but with a fluid sourceschematically shown coupled to the cannula and one of the fluid bladdersealing members shown inflated;

FIG. 36 is a view similar to FIG. 35, but with the cannula advancedfurther into the body cavity and a different fluid bladder sealingmember shown inflated; and

FIG. 37 is a view similar to FIG. 36, but with two fluid bladder sealingmembers shown inflated.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

While the invention is susceptible to various modifications andalternative forms, a specific embodiment thereof has been shown by wayof example in the drawings and will herein be described in detail. Itshould be understood, however, that there is no intent to limit theinvention to the particular form disclosed, but on the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the invention as defined by theappended claims.

FIRST EMBODIMENT OF THE INVENTION

Referring to FIGS. 1, 4, and 5 there is shown a medical apparatus 10 ofthe present invention advanced through an opening 26 in a wall 28 of abody cavity 34. The medical apparatus 10 includes a sleeve 18 having apassageway 24 extending therethrough. The sleeve 18 includes a number ofsealing members 20. Each sealing member 20 has an end portion 294 (seeFIG. 6) and an end portion 296 (see FIG. 6). End portion 294 of eachsealing member 20 is attached to a distal end 22 of sleeve 18 (see FIG.6). Alternatively, each sealing member 20 can be attached to an exteriorsidewall 113 (see FIG. 7) of sleeve 18. The medical apparatus furtherincludes an actuator 38 and a trocar assembly 12. The actuator 38includes a guide member 40 and handles 42.

Trocar assembly 12 includes a cannula 14 having a lumen 19 extendingtherethrough, a trocar 16 (sometimes referred to as an "obturator"), anda valve assembly 254 (see FIG. 27). Trocar 16 is positioned within lumen19 of cannula 14 (see FIG. 5). Valve assembly 254 is secured to an endof cannula 14 as shown in FIG. 27. As illustrated in FIG. 2, cannula 14is positioned within passageway 24 of the sleeve 18 such that cannula14, sealing members 20, and guide member 40 are all respectively nestedwithin each other in a substantially concentric relationship. Note thattrocar 16 is not shown in FIG. 2.

Trocar 16 is positionable between a first trocar position and a secondtrocar position. Trocar 16 is positioned at the first trocar positionwhen trocar 16 is positioned within lumen 19 of cannula 14 as shown inFIG. 5. Trocar 16 is positioned at the second trocar position when it iscompletely removed from lumen 19 of cannula 14 as shown in FIG. 27.

As shown in FIG. 26, cannula 14 is positioned within passageway 24 ofsleeve 18 such that a space 270 is defined between interior sleevesidewall 266 and exterior cannula sidewall 268. In addition, a gasket264 or bearing member is secured to interior sleeve sidewall 266 with anadhesive 272 such that gasket 264 extends into space 270 and contactsexterior cannula sidewall 268. Gasket 264, interior sleeve sidewall 266,and exterior cannula sidewall 268 form a seal or gas tight junction soas to prevent fluid communication between an area inside of body cavity34 and an area outside of body cavity 34 through space 270. However, itshould be appreciated that gasket 264 allows cannula 14 to slidably moverelative to sleeve 18 in a direction indicated by arrow 274, and in adirection opposite to the direction indicated by arrow 274. In addition,cannula 14 is positionable relative to sleeve 18 between a first cannulaposition and a second cannula position. Cannula 14 is positioned withinpassageway 24 of sleeve 18 when cannula 14 is positioned at the firstcannula position as shown in FIG. 27. Cannula 14 is completely removedfrom passageway 24 when cannula 14 is positioned at the second cannulaposition as shown in FIG. 31.

Guide member 40 is slidably mounted onto sleeve 18 so it can be movedbetween a first position as shown in FIG. 4 and a second position asshown in FIG. 5. The double headed arrow 93 of FIG. 1 shows thedirection of movement of guide member 40. Specifically, FIGS. 1-4 showguide member 40 placed in the first position, whereas FIGS. 5 and 7 showguide member 40 placed in the second position. As illustrated in FIGS.1, 3, 5, and 7, the position of guide member 40 controls the movement ofsealing members 20 between a first orientation and a second orientation.The sealing members 20 are positioned in the first orientation when thesealing members 20 are positioned in a substantially parallelrelationship with passageway 24 of sleeve 18, as shown in FIGS. 1-4.When positioned in the first orientation, second end portions 296 ofsealing members 20 cooperate to define an orifice 298 (see FIG. 2). Thesealing members 20 are positioned in the second orientation when thesealing members 20 are positioned in a substantially orthogonalrelationship with passageway 24 of sleeve 18 as shown in FIGS. 5-7.Moreover, as depicted in FIG. 6, when sealing members 20 are positionedin the second orientation they extend from the distal end 22 of sleeve18 so as to overlap one another, thereby completely surroundingpassageway 24 of sleeve 18.

Thus it should be appreciated that sleeve 18 and sealing members 20 areformed such that when no force is applied to sealing members 20 theyspontaneously assume their second orientation (see FIGS. 5-7). Moreover,sealing members 20 are flexibly attached to distal end 22 such that whenforce is applied (i.e. the force applied by sliding guide member 40 overthe sealing members 20) the sealing members 20 assume their firstorientation (see FIGS. 1-4).

FIG. 6 shows sealing members 20 extending to form an annular flange.However, it should be appreciated that the present invention is notlimited to the geometric shape formed by sealing members 20. Forexample, other geometric shapes are contemplated, such as square or ovalshaped configurations. Moreover, a single sealing member extending froma distal end of a sleeve (or other medical device), or a number ofnon-overlapping or overlapping sealing members spaced around a distalend of a sleeve (or other medical device) are also contemplated.Furthermore, sealing members having perforations thereon which can betorn and separated prior to positioning in contact with the interiorsurface of a body cavity wall are also contemplated.

Sleeve 18 and guide member 40 can be made from any plastic materialwhich is conventionally used in the medical device arts. Such materialwould be compatible with insertion into a body cavity. It should also benoted that the guide member used in the present invention can bemanufactured to a size which only adds a minimal amount of bulk to thediameter of a trocar assembly. By doing so, trauma to the body cavitywall upon insertion of the medical apparatus of the present inventionwill be reduced.

Handles 42 can be made of any material having the appropriate beamstrength to move guide member 40 from the first position to the secondposition.

When performing a medical procedure with medical apparatus 10, such aslaparoscopic surgery, guide member 40 is placed into the first position(see FIGS. 1-4) so that sealing members are maintained in their firstorientation. Trocar 16 of medical apparatus 10 is then placed in contactwith, and advanced through, wall 28 of a body cavity 34 to create anopening 26 (i.e. the port site wound). Preferably, sleeve 18, cannula14, and trocar 16 are simultaneously advanced through the opening 26 andinto body cavity 34. It should be appreciated that tabs may bepositioned on the sleeve 18 to prevent handles 42 and guide member 40from being forced in the direction of arrow 94 (and therefore towardtheir second position (see FIGS. 5 and 7)) during the advancement ofmedical apparatus 10 through wall 28. It should also be appreciated thatmaintaining guide member 40 in its first position, and therefore sealingmembers 20 in their first orientation, facilitates the advancement ofsleeve 18 through opening 26 and into body cavity 34.

Once distal end 22 of medical apparatus 10 enters into body cavity 34through opening 26, handles 42 are moved away from opening 26 in thedirection of arrow 94 (see FIG. 1) so as to slide guide member 40 to thesecond position (see FIGS. 5 and 7), thereby allowing sealing members 20to assume their second orientation. Once sealing members 20 have assumedtheir second orientation they are positioned to contact the interiorsurface 56 of the body cavity wall 28 (see FIG. 5). Once sealing members20 are in their second orientation and positioned in contact with theinterior surface 56 of the body cavity wall 28 they surround a space 36defined between the opening 26 and the sleeve 18. Positioning sealingmembers 20 in the above described manner prevents fluid communicationbetween an area inside of body cavity 34 and an area outside of bodycavity 34 through space 36.

In addition, it should be understood that a non-perforating ridge (notshown) extending from the surface of the sealing members 20 andcontacting interior surface 56 of body cavity wall 28 is alsocontemplated. Such a ridge will also contact interior surface 56 of bodycavity wall 28 and assist in preventing fluid communication between thearea inside of the body cavity 34 and the area outside of the bodycavity through space 36 defined between opening 26 and sleeve 18. Theaforementioned ridge will also keep sealing members 20 stationaryrelative to interior surface 56 of body cavity 34 during manipulationsof cannula 14.

Referring now to FIGS. 27-31, once the sealing members 20 are positionedas described above, trocar 16 is moved to the second trocar position(i.e. trocar 16 is completely removed from cannula 14 (see FIG. 27)). Aninsufflation gas, such as CO₂, is then pumped through valve 256, valveassembly 254, lumen 19 of cannula 14, and into body cavity 34. A shaft262 of a medical instrument 258 is inserted through lumen 19 of cannula14 such that a set of jaws 260 attached to an end 263 of shaft 262 ispositioned within body cavity 34. It should be understood that in orderto successfully complete the medical procedure jaws 260 will bepositioned at different locations within body cavity 34 by advancing orwithdrawing shaft 262 through lumen 19 of cannula 14. For example, jaws260 may have to be positioned at a certain location within body cavity34 in order to grasp a tumor (not shown).

As previously discussed, when cannula 14 is positioned at the firstcannula position (i.e. cannula 14 is positioned within passageway 24 ofsleeve 18), cannula 14 is slidably mounted within passageway 24 ofsleeve 18. Therefore, in addition to adjusting the position of shaft 262relative to cannula 14, the position of cannula 14 can be adjustedrelative to sleeve 18 to position jaws 260 within body cavity 34. Forexample, as shown in FIG. 28, cannula 14 can be positioned relative tosleeve 18 such that a length L₁ of cannula 14 extends into body cavity34. As shown in FIG. 29, cannula 14 can also be moved in an axialdirection relative to sleeve 18 as indicated by arrow 274 such thatvalve assembly 254 contacts an end 276 of sleeve 18. At this position,the cannula 14 extends a length L₂ into body cavity 34. Moreover, asshown in FIG. 30, cannula 14 can be moved in an axial direction relativeto sleeve 18 as indicated by arrow 286 such that an end 284 of cannula14 is positioned substantially adjacent to an end 282 of sleeve 18.

Being able to adjust the position of jaws 260 (or the distal end of anymedical instrument positioned within lumen 19 of cannula 14) by movingcannula 14 relative to sleeve 18 in the above described manner is animportant aspect of the present invention since it provides the surgeonwith added flexibility in moving jaws 260 to the appropriate positionwithin body cavity 34 to successfully complete the medical procedure.

In addition, it should be appreciated that cannula 14 can be movedrelative to sleeve 18 in the above described manner while maintainingthe contact between sealing members 20 and the interior surface 56 ofbody cavity wall 28. Maintaining this contact is another importantaspect of the present invention since it ensures that opening 26 isprotected against tumor cell implantation or contamination with aninfectious agent during the above described movement of cannula 14relative to sleeve 18. This is in contrast to the situation where acannula cannot move in relation to the sealing members in the abovedescribed manner (i.e. the cannula and the sealing members move as asingle unit). In this situation, advancing the cannula further into bodycavity 34 will also advance the sealing members further into body cavity34, thus causing the sealing members to disengage interior surface 56 ofbody cavity wall 28. Disengaging the sealing members from interiorsurface 56 allows fluid communication between an area inside of bodycavity 34 and an area outside of body cavity 34 through space 36 (e.g.gas or body fluids my be advanced from an area inside body cavity 34 toan area outside of body cavity 34 through space 36). This fluidcommunication may result in tumor cells being implanted in a sidewall290 (see FIGS. 28 and 32) of opening 26. The fluid communication canalso result in sidewall 290 being contaminated with an infectious agent.

After completing the medical procedure utilizing medical apparatus 10,medical instrument 258 is withdrawn from lumen 19 of cannula 14. Asshown in FIG. 31, cannula 14 is then moved relative to sleeve 18 in theaxial direction indicated by arrow 287 until cannula 14 is positioned atthe second cannula position (i.e. cannula 14 is completely withdrawnfrom passageway 24 of sleeve 18). Removing cannula 14 from sleeve 18allows the insufflation gas to rapidly escape body cavity 34 throughpassageway 24 of sleeve 18 as shown by arrows 288. Having sleeve 18positioned within opening 26 and sealing members 20 in contact withinterior surface 56 of the body cavity wall 28 protects sidewall 290 ofopening 26 from coming into contact with aerosolized tumor cells orinfectious agents carried by the escaping insufflation gas.

Once substantially all the insufflation gas has escaped from body cavity34 (i.e. body cavity 34 has been desufflated) handles 42 are movedtoward opening 26 in a direction opposite to arrow 94 so as to slideguide member 40 to the first position (see FIGS. 1-4). The movement ofguide member 40 to the first position forces sealing members 20 toassume their first orientation (see FIGS. 1-4), thereby facilitating theremoval of sleeve 18 from opening 26. In addition, it should beappreciated that positioning sealing members 20 in the first orientationprevents any infectious or cancerous cells adhered to surface 11 (seeFIG. 5) of sealing members 20 from coming into contact with sidewall 290as sleeve 18 is withdrawn from opening 26.

Thus, it should be understood that sleeve 18 including sealing members20 are the last components to be removed from body cavity 34 by thesurgeon (not shown). Removing sleeve 18 including sealing members 20last ensures that opening 26 (i.e. the port site wound) remainsprotected against tumor cell implantation or contamination with aninfectious agent until completion of the medical procedure.

It should be appreciated that the probability of contaminating opening26 with infectious or cancerous cells during a medical procedure is muchgreater when trocar assembly 12 is not equipped with sleeve 18.Specifically, when trocar assembly 12 is not equipped with sleeve 18 asshown in FIG. 32, an exterior surface 278 of cannula 14 can come intodirect contact with sidewall 290 of opening 26. This direct contact canresult in the contamination of opening 26 since tumor cells andinfectious agents have been shown to become adhered to exterior surface278 during a medical procedure. Therefore, as cannula 14 is moved in andout of opening 26 in the absence of sleeve 18, tumor cells and/orinfectious agents adhered to exterior surface 278 are brought intodirect contact with sidewall 290 of opening 26. The aforementioneddirect contact can result in tumor cells being implanted into sidewall290, or sidewall 290 being contaminated with an infectious agent.However, having trocar assembly 12 equipped with sleeve 18, as shown inFIG. 28, provides a barrier between sidewall 290 and cannula 14 whichprevents tumor cells from coming into contact with, and thus becomingimplanted into, sidewall 290. In addition, the barrier provided bysleeve 18 prevents sidewall 290 from becoming contaminated with aninfectious agent.

In addition, when trocar assembly 12 is not equipped with sleeve 18 andcannula 14 is removed from opening 26 at the end of the medicalprocedure, sidewall 290 of opening 26 comes into direct contact with theinsufflation gas as it escapes from body cavity 34 in the directionindicated by arrows 292 as shown in FIG. 33. Therefore, aerosolizedtumor cells may become implanted into sidewall 290 as a result of thecontact with the escaping insufflation gas. In addition, sidewall 290can become contaminated with infectious agents as a result of cominginto contact with the escaping insufflation gas. However, as previouslydiscussed, having trocar assembly 12 equipped with sleeve 18 provides abarrier between sidewall 290 and the escaping insufflation gas uponremoval of cannula 14 as shown in FIG. 31. The barrier provided bysleeve 18 including sealing members 20 prevent sidewall 290 from cominginto contact with aerosolized tumor cells or infectious agents carriedby the escaping insufflation gas.

SECOND EMBODIMENT OF THE INVENTION

Now referring to FIG. 19, there is shown a medical apparatus 166 similarto the medical apparatus 10 shown in FIG. 1. Medical apparatus 166 isshown advanced through an opening 212 in a wall 214 of a body cavity193. Medical apparatus 166 includes a trocar assembly 176, a sleeve 168,a vacuum source V, and an air supply A.

Vacuum source V can be manually operated or power driven. Examples ofvacuum sources which can be used in the present invention include a wallsuction apparatus, aspirator pumps, syringes, or any other convenientoperating vacuum source. Similarly, air supply A can be manuallyoperated or power driven. Examples of air supplies which can be used inthe present invention include an air compressor, a syringe, or any otherconvenient operating air supply.

As shown in FIGS. 20, 21, and 22, sleeve 168 has a number of sealingmembers 171 extending therefrom and a passageway 169 extendingtherethrough. Sleeve 168 also has a channel 195 defined therein (seeFIGS. 21 and 22). Channel 195 is in fluid communication with a valve 182(see FIG. 19) attached to sleeve 168. Valve 182 can be any of a numberof well known valves capable of maintaining and then releasing a vacuum,as long as the size of the valve does not interfere with the operationof the medical apparatus into which sleeve 168 is incorporated. Forexample, valve 182 can be a trumpet valve or a conventional two or threeway stop cock valve. It should be understood that channel 195 isselectively placed in fluid communication with vacuum source V via valve182, hose 218, and a hose 219 by manipulating a valve 167 (see FIG. 19).In a similar fashion, channel 195 is selectively placed in fluidcommunication with air supply A via valve 182, hose 218, and a hose 221by manipulating valve 167. Valve 167 can be any valve (e.g. a three waystop cock valve) capable of directing a flow of air.

As shown in FIG. 20, adjacent sealing members 171 have a web 174connected therebetween. Sealing members 171 are movable relative tosleeve 168 between a first orientation in which sealing members 168 arepositioned in a substantially parallel relationship with passageway 169(see FIG. 21), and a second orientation in which sealing members 171 arepositioned substantially perpendicular to passageway 169 (see FIG. 22).It should be understood that various sized sealing members 171 and webs174 are contemplated to facilitate the movement of the sealing members171 between the first and second orientation.

Referring back to FIG. 19, trocar assembly 176 includes a cannula 178and a trocar 180. Cannula 178 has a lumen 179 (see FIG. 20) definedtherein, and trocar 180 is positioned within lumen 179. However, itshould be understood that trocar 180 is completely removable from lumen179 (note that FIGS. 20, 21 and 22 show trocar 180 completely removedfrom lumen 179). Trocar assembly 176 is positioned within passageway 169of sleeve 168. It should be appreciated that cannula 178 can be movedrelative to sleeve 168 while still maintaining the contact betweensealing members 171 and interior surface 216 of body cavity 193 (seeFIG. 19), and between webs 174 and interior surface 216 of body cavity193. It should also be appreciated that cannula 178 is completelyremovable from passageway 169 of sleeve 168. Being able to (1) movecannula 178 relative to sleeve 168 and (2) completely remove cannula 178from sleeve 168 has all the same advantages as described above inreference to sleeve 18.

As shown in FIGS. 21, 22, 23a, and 23b sleeve 168 includes an actuator172 secured to sealing members 171. As shown more clearly in FIG. 23a,actuator 172 includes a flexible cover 190, a wall segment 198, and awall segment 200. Wall segment 198 is attached to sealing member 171 andwall segment 200 is attached to sleeve 168. In addition, wall segment198 and wall segment 200 are connected to each other so as to form a "V"shaped structure 209 (see FIG. 23a). One edge of flexible cover 190 isattached to a portion of wall segment 200. The edge of flexible cover190 opposite to the edge attached to wall segment 200 is attached to aportion of wall segment 198, such that wall segment 198, flexible cover190, and wall segment 200 define a ring-shaped chamber 192 whichcompletely surrounds cannula 178. Actuator 172 also includes a flexiblehinge 208 which connects sealing member 171 to sleeve 168. Flexiblehinge 208 includes a corrugated area 197 having a number of corrugations199 formed thereon. It should be appreciated that the various componentsof actuator 172 are made from any fluid impervious plastic or rubbermaterial which is conventionally used in the medical device arts and iscompatible with insertion into body cavity 193.

As shown in FIGS. 23a and 23b, wall segment 200 has a port 194 definedtherethrough. Port 194 is in fluid communication with chamber 192. Port194 is also in fluid communication with channel 195. Thus it should beappreciated that chamber 192 can be selectively placed in fluidcommunication with vacuum source V or air supply A via port 194 so as toevacuate air from or advance air into chamber 192. It should also beappreciated that wall segment 200 can have several ports substantiallyidentical to port 194 defined therein, and sleeve 168 can have severalchannels substantially identical to 195 defined therein, so that chamber192 can be placed in fluid communication with air supply A or vacuumsource V utilizing a several ports and channels.

When performing a medical procedure with medical apparatus 166, such aslaparoscopic surgery, valve 167 (see FIG. 19) is positioned such thatchamber 192 is in fluid communication with air supply A. Air (otherfluids, such as CO₂, are also contemplated) is then advanced intochamber 192 by air supply A through a fluid path defined by hose 221,valve 167, hose 218, valve 182, and channel 195.

Advancing air in the above described manner inflates chamber 192. Asshown in FIG. 23a, once chamber 192 is inflated, the pressure of the aircontained therein urges wall segment 198 away from wall segment 200 in adirection indicated by arrow 204. Urging wall segment 198 in the abovedescribed manner forces sealing member 171 to be positioned in the firstorientation.

Once sealing members 171 are in the first orientation, trocar 180 ispositioned in contact with wall 214 of body cavity 193. Trocar 180 isadvanced through wall 214 in a direction indicated by arrow 220 (seeFIG. 19) to create opening 212. It should be appreciated that havingsealing members 171 positioned in the first orientation facilitatesadvancement of sleeve 168 through opening 212. In addition, it should beappreciated that preferably, sleeve 168, cannula 178, and trocar 180 aresimultaneously advanced through opening 212 and into body cavity 193.

Once sealing members 171 are completely within body cavity 193 valve 167(see FIG. 19) is positioned such that chamber 192 is in fluidcommunication with vacuum supply V. Air is then withdrawn from chamber192 by vacuum supply V through a fluid path defined by hose 219, valve167, hose 218, valve 182, (see FIG. 19) and channel 195 (see FIG. 23a).Withdrawing air in the above described manner creates a vacuum inchamber 192. As shown in FIG. 23b, the vacuum created in chamber 192forces flexible cover 190 to collapse into chamber 192. The collapse offlexible cover 190 into chamber 192 in the above described manner causeswall segment 198 to move toward wall segment 200 in a directionindicated by arrow 205. Movement of wall segment 198 toward wall segment200 forces sealing member 171 to bend at flexible hinge 208 and move inthe direction indicated by arrow 205. Bending sealing member 171 atflexible hinge 208 causes corrugations 199 (see FIG. 23a) to flatten out(see FIG. 23b) thereby enhancing the flexibility of sealing member 171at flexible hinge 208. Sealing member 171 continues to move in thedirection indicated by arrow 205 until chamber 192 is substantiallycompletely collapsed, and flexible cover 190 is folded within chamber192 thereby positioning sealing member 171 at the second orientation asshown in FIG. 22.

Therefore, it should be understood that withdrawing air from chamber 192in the above described manner causes sealing members 171 to bepositioned at the second orientation as shown in FIG. 22, and advancingair into chamber 192 in the previously described manner causes sealingmembers 171 to be positioned at the first orientation as shown in FIG.21. It should also be understood that since the webs 174 are attached tosealing members 171, webs 174 move with sealing members 171 between thefirst and second orientation. In addition, it should be appreciated thateach web 174 allows sealing members 174 to move relative to one another,which facilitates the movement of sealing members 171 between the firstorientation and the second orientation.

As shown in FIG. 19, once sealing members 171 have assumed the secondorientation they are positioned in contact with interior surface 216 ofbody cavity 193. Each web 174 is also positioned in contact withinterior surface 216. Positioning sealing members 171 and each web 174in contact with interior surface 216 prevents fluid communicationbetween an area inside of body cavity 193 and an area outside of bodycavity 193 through a space 213 (see FIG. 19) defined between opening 212and sleeve 168.

After completion of the medical procedure, all contaminated instruments(not shown), specimens (not shown), and the cannula 178 are withdrawnfrom the body cavity through passageway 169 of sleeve 168. The bodycavity is then desufflated as the insufflation gas exits the body cavitythrough passageway 169. Air is then advanced into chamber 192 in thesame manner as described above, thereby returning each sealing member171 to the first orientation (see FIG. 21). (Note that returning sealingmember 171 to the first orientation causes corrugations 199 to reform asshown in FIG. 23a). Sleeve 168 is then withdrawn from opening 212 (seeFIG. 19) in wall 214 of body cavity 193. Thus, it should be understoodthat sleeve 168 and sealing members 171 are the last components to beremoved from body cavity 193 by the surgeon. Removing sleeve 168 andsealing members 171 last ensures that opening 212 (i.e. the port sitewound) remains protected against tumor cell implantation orcontamination with an infectious agent until completion of the medicalprocedure.

THIRD EMBODIMENT OF THE INVENTION

Now referring to FIG. 8, there is shown a medical apparatus 62 similarto the medical apparatus 10 shown in FIG. 1. Medical apparatus 62 isshown advanced through an opening 70 in a wall 66 of a body cavity 74.The medical apparatus 62 includes a sleeve 82 having a plurality ofperforations 86 defined in its proximal end portion and an adhesivematerial disposed on its outer surface 91. The sleeve 82 includes anumber of sealing members 64 positioned in a second orientationextending from distal end 78. The medical apparatus 62 further includesa guide member 72 positioned in the second position. Medical apparatus62 also includes a strippable liner 84, surrounding and in contact with,the adhesive material disposed on outer surface 91. The strippable linerhas perforations 86 formed thereon.

Medical apparatus 62 is used in the same manner as described above withreference to medical device 10. However, once the sealing members arepositioned in contact with an interior surface 68 of body cavity wall66, strippable liner 84 is torn along perforations 86 to expose theadhesive material disposed on the outer surface 91 of sleeve 82. Asshown in FIG. 9, sleeve 82 is then torn along perforations 86 down toguide member 72 to form a number of elongated strips 88 having a firstsurface 95 with the adhesive disposed thereon. It is also contemplatedthat sleeve 82 may be formed from a material having the physicalproperty of molecular orientation whereby a tear in the material runsreadily only in a longitudinal direction along the length of sleeve 82.A sleeve formed from such a material will eliminate the need for theabove described perforations. Once the elongated strips 88 are formed, afirst surface 95 of each strip 88 is attached to an exterior surface 90of body cavity wall 66 with the adhesive.

An important aspect of using elongated strips 88 in the above describedmanner is that they cooperate with sealing members 64 to stabilize theposition of medical apparatus 62 in opening 70. The attachment ofelongated strips 88 to the exterior surface 90 of body cavity wall 66also keeps sealing members 64 in contact with interior surface 68. Thisensures that no fluid communication exists between an area inside of thebody cavity 74 and an area outside the body cavity through the space 97defined between the opening 70 and the sleeve 82.

FOURTH EMBODIMENT OF THE INVENTION

Now referring to FIG. 10, there is shown a medical apparatus 100 similarto the medical apparatus 10 shown in FIG. 1. Medical apparatus 100 isshown advanced through an opening 110 in a wall 108 of a body cavity.Medical apparatus 100 includes a sleeve 106 having a number of sealingmembers 104 positioned in the second orientation extending from distalend 105 of sleeve 106, and in contact with interior surface 112 of bodywall 108. The medical apparatus 100 further includes an actuator 102with a guide member 103 located in the second position. Medicalapparatus 100 also includes a lock member 114 positioned in contact withsleeve 106 and exterior surface 111 of body cavity wall 108.

FIG. 11 is an elevational view of the lock member 114 taken along theline 11--11 of FIG. 10, with the body wall and the rest of the medicalapparatus 100 shown removed for clarity of description. The lock member114 is divided by a seam 120 into a first portion 128 and a secondportion 126. Lock member 114 includes a fastening mechanism (which willbe discussed in greater detail below) for fastening the first portion128 to the second portion 126. The lock member also includes apositioning element 122 which defines an orifice 124 for acceptingsleeve 106. The first portion 128 and the second portion 126 cooperatewith each other so as to securely grasp the sleeve 106 therebetween.Lock member 114 can be made from any plastic material which isconventionally used in the medical device arts.

First portion 128 and second portion 126 can be separated by actuatingthe fastening mechanism (which will be discussed in detail below) andmoving first portion 128 and second portion 126 in the direction ofarrows 132 and 130, respectively. Separation of lock member 114facilitates the insertion and removal of sleeve 106 from orifice 124.

As shown in FIGS. 11-14, the fastening mechanism includes a shaft 134extending from an edge 142 of first portion 128. (It should beappreciated that, as illustrated in FIG. 12 second portion 126 has thesame elements of the fastening mechanism as first portion 128. However,as discussed below, the fastening mechanism is arranged on secondportion 126 to cooperate with those disposed on first portion 128.) Thefastening mechanism also includes a clip 118 that obliquely extends froman end of shaft 134. Clip 118 is attached to shaft 134 using knownmanufacturing techniques that allows it to flex or bend around its pointof attachment to shaft 134 in the directions indicated by arrow 141 (seeFIG. 14).

As shown in FIGS. 12 and 13, the fastening mechanism also includes achannel 136 defined in edge 142, which is connected to an aperture 116formed on second surface 140 of first portion 128. Channel 136 isadapted to receive clip 118 and shaft 134, and has the appropriateheight dimension so that clip 118 must bend toward shaft 134 upon itsentrance into channel 136. Medical apparatus 100 is used in the samemanner as described above in reference to medical device 10 (see FIG.1). However, once sealing members 104 are positioned in contact withinterior surface 112, first portion 128 and second portion 126 of lockmember 114 are positioned relative to each other so that the fasteningmechanism elements can cooperate to join first portion 128 and secondportion 126 along seam 120 (see FIG. 12). First portion 128 and secondportion 126 are also positioned relative to sleeve 106 such that thesleeve 106 is positioned in orifice 124 and in contact with positioningelement 122 when these portions are joined along seam 120. Once firstportion 128 and second portion 126 are positioned in the above describedmanner, they are moved toward each other such that clip 118 and shaft134 extending from second portion 126 enters channel 136 of firstportion 128, and clip 118 and shaft 134 extending from first portion 128enters the channel (not shown; identical to channel 136) located on theedge of second portion 126. As described above, as each clip 118 entersits respective channel 136 it is bent toward shaft 134 until enteringits aperture 116. Once positioned in aperture 116 each clip snaps backto its unbent configuration where it engages wall 117 (see FIG. 12)thereby preventing the separation of the first portion 128 and secondportion 126. The lock member can then be moved along the longitudinalaxis of sleeve 106 until it contacts the exterior surface 111 of bodycavity wall 108. As a result, wall 108 is trapped or "sandwiched"between lock member 114 and sealing member 104 thereby locking medicalapparatus 100 into position with respect to wall 108. It should beunderstood that lock member 114 can also have any of the well knownmedical adhesives disposed thereon to facilitate its engagement withexterior surface 111. It should also be understood that a fasteningmechanism utilizing velcro type fasteners can also be used in thepresent invention.

An important aspect of using lock member 114 in the above describedmanner is that the sealing members 104 remain in contact with interiorsurface 112 during the manipulations of medical apparatus 100 requiredby a medical procedure. By keeping sealing members 104 in contact withinterior surface 112 fluid communication between an area inside of thebody cavity and an area outside of the body cavity through opening 110is prevented. Thus, the port site wound is protected from being exposedto potentially harmful substances including exfoliated cancer cellsand/or infectious agents.

Another advantage of using lock member 114 is that it helps maintain asubstantially gas tight seal between the interior and exterior of a bodycavity, which ensures that no unexpected loss of a pneumoperitoneum willoccur during a medical procedure. This is especially true when anadhesive is used to attach lock member 114 to exterior surface 111. Itshould be appreciated that preventing an uncontrolled loss of thepneumoperitoneum is important since such a loss can complicate themedical procedure being performed, and increase the potential that theport site wound will be contaminated with tumor cells or infectiousmicrobes.

The use of lock member 114 may also eliminate the need for anyone tohold medical apparatus 100 in the appropriate position during surgery,thereby freeing them to perform other tasks. This is true since thefirst portion 128 and the second portion 126 cooperate with each otherto securely grasp the sleeve 106 therebetween.

Once the medical procedure is completed, lock member 114 can be removedby depressing clip 118 (for example with a finger) toward shaft 134,(see FIG. 14) such that clip 118 can be inserted into channel 136, andmoving first portion 128 and second portion 126 in the direction ofarrows 132 and 130, respectively (see FIG. 11). Medical apparatus 100can then be removed from the opening 110 as described above in referenceto medical apparatus 10.

FIFTH EMBODIMENT OF THE INVENTION

Now referring to FIGS. 15-17, there is shown a sleeve 148 similar tosleeve 18 shown in FIG. 1 or sleeve 106 shown in FIG. 10. Sleeve 148 canbe substituted for sleeve 18 or sleeve 106 in medical apparatus 10 or100, respectively. Moreover, sleeve 148 is used in a similar fashion asdescribed for sleeve 18 or sleeve 106. However, as discussed in greaterdetail below, sleeve 148 includes a single sealing member 150 thatdefines a flexible gas impervious bag having a void 157 therein (seeFIG. 18). One flexible gas impervious bag which may be used with somemodification is disclosed in U.S. Pat. No. 3,762,404 issued to Sakitawhich is herein incorporated by reference. In particular, the void 157contains a charge of small particles or beads 156 which consolidate orinterengage into a rigid structure when the void 157 is evacuated. Asshown in FIG. 16, the sleeve 148 has a passageway 153 extendingtherethrough adapted to accept a trocar assembly (not shown) whichincludes a cannula and a trocar. Sleeve 148 also has a number of supportmembers 152 extending from a distal end of sleeve 148 (see FIG. 16)which engage sealing member 150. Support members 152 are formed suchthat when no force is applied to them they spontaneously assume thesecond orientation which is in a substantially orthogonal relationshipwith passageway 153 (see FIG. 16) thereby lifting and supporting theengaged sealing member 150 in its second orientation (see FIGS. 15 and16). Moreover, support members 152 are flexibly attached to the distalend of sleeve 148 such that when force is applied (i.e. the forceapplied by sliding a guide member over support members 152 and sealingmember 150) the support members 152 and the sealing member 150 assumetheir first orientation (i.e. positioned in a substantially parallelrelationship with passageway 153).

As shown in FIGS. 15 and 17, sleeve 148 also includes a valve 144 and avacuum line 146 in fluid communication with void 157. Valve 144 can havea well known female Luer-lock connector for attaching a vacuum hose (notshown) thereto. Moreover, valve 144 can be any of a number of well knownvalves capable of maintaining and then releasing a vacuum, as long asthe size of the valve does not interfere with the operation of themedical apparatus into which sleeve 148 is incorporated. For examplevalve 144 can be a trumpet valve or a conventional two or three way stopcock valve.

As illustrated in FIG. 18, the bag structure defined by sealing member150 includes a first wall 158 and a second wall 160 with interior void157 therebetween. The bag structure also includes a number of partitions162 secured to and extending between first wall 158 and second wall 160that divide interior void 157 into a number of compartments. Thesepartitions 162 confine a portion of the charge of beads 156 into theirrespective compartment. It should be appreciated that having the beads156 divided and confined into a number of compartments prevents thebeads from being redistributed by gravity as sealing member 150 is movedbetween its first and second orientations, as well as, any movementwhich the beads are subjected to prior to evacuation of void 157. Eachpartition 162 has a screen 164 mounted therein which is adapted to allowthe flow of a fluid therethrough but prevents a flow of beads from onecompartment to another. Thus all the compartments are in fluidcommunication with one another and only one valve 144 and one vacuumline 146 are required to evacuate interior void 157.

The beads 156 occupying interior void 157 must be sufficiently rigid towithstand the stresses that result when they interengage upon evacuationof void 157. Beads 156 must also have a high mechanical strength so thatvoid 157 can be repeatedly evacuated without the accompanying attritionor fracture of the beads 156. Beads 156 should also be elasticallydeformable such that when void 157 is evacuated they can move freelyinto close interengagement to form a stable, rigid structure.

Beads of expanded plastic material, such as polystyrene and polyvinylchloride are preferred because of their high mechanical strength,elastic deformability and low specific gravity. The expression "specificgravity" is intended to mean a true specific gravity. Thus, when suchbeads are made hollow the specific gravity of the beads is representedby its weight divided by its total volume including the hollow spacetherein. The specific gravity of the beads used in the present inventionshould be in the range of from about 0.1 to about 0.6. Such values arereadily attainable with foamed synthetic resins, although other materialcan be used for beads 156 when they have a low specific gravity in therange specified above and satisfy the mechanical strength and elasticdeformability requirements.

The beads used in the present invention can be from about 0.5 to about 2millimeters in diameter. Moreover, beads which are uniform in size andshape can be used, but a mixture of substantial portions of beads of atleast two materially different sizes within the indicated range can alsobe used.

Any appropriate vacuum source (not shown) can be used to evacuate void157. Such a vacuum source can be manually operated or power driven.Examples of vacuum sources which can be used in the present inventioninclude a wall suction apparatus, aspirator pumps, syringe, or any otherconvenient operating vacuum source.

A medical apparatus incorporating sleeve 148 is used in a similar manneras described above in reference to medical device 10 and medical device100. However, once sealing member 150 is positioned in contact with aninterior surface of a body cavity wall, an end of a vacuum hose (notshown) is attached to valve 144 with the other end being attached to avacuum source (not shown). A vacuum is pulled through valve 144 andvacuum line 146 thereby evacuating each compartment of interior void157. It should be understood that since each partition 162 has a screen164 therein, they will be in fluid communication with one another,therefore only one valve 144 and vacuum line 146 is required to evacuateinterior void 157. As the vacuum is created inside interior void 157 theoutside pressure present within the body cavity (e.g. an insufflatedperitoneum) forces the beads 156 together into close interengagement sothey cannot move. This interengagement of beads 156 upon evacuation ofinterior void 157 causes beads 156 to form a stable rigid structure,thereby converting sealing member 150 from its pre-evacuation state ofbeing a soft, pliable, deformable, flaccid structure (i.e. bean baglike) to its post-evacuation state of a stable rigid structure. Whensealing member 150 is in its post-evacuation state, and in contact withan interior surface of a body cavity wall it effectively prevents fluidcommunication between an area inside of the body cavity and an areaoutside of the body cavity through a space defined between an opening ina wall of the body cavity and sleeve 148.

Once the medical procedure is completed, the surgeon (not shown) removesspecimens (not shown) and instruments (not shown) from the body cavityand releases the intra-abdominal pressure. Then the vacuum is releasedand gas re-enters interior void 157 thereby disrupting theinterengagement of beads 156. As a result sealing member 150 returns toits soft, pliable pre-evacuation state whereupon support member 152 (andtherefore sealing member 150) are forced to assume their firstorientation in the same manner as described above in reference tomedical apparatus 10. Then the medical apparatus incorporating sleeve148 is then withdrawn from the opening created in the body cavity wall.

An important aspect of using sealing member 150 in the above describedmanner is that in its pre-evacuation state its soft pliable natureallows it to conform to any irregular or protruding structuresencountered on the interior surface of the body cavity wall. Then uponevacuation, sealing member 150 forms a rigid structure surrounding theencountered structure thus providing a fluid tight seal between theinterior of the body cavity and the port site wound.

SIXTH EMBODIMENT OF THE INVENTION

Now referring to FIGS. 24 and 25, there is shown a portion of a sleeve238, a portion of sealing member 226, and a portion of a support member240. Sleeve 238, sealing member 226, and support member 240 are somewhatsimilar to sleeve 148, sealing member 150 and support members 152 shownin FIGS. 15-17. Sleeve 238, sealing member 226 and support member 240can be substituted for sleeve 148, sealing member 150, and each supportmember 152, respectively. In addition, sleeve 238, sealing member 226,and support member 240 are used and constructed in a somewhat similarfashion as described above for sleeve 148 and sealing member 150.However, sealing member 226 has a corrugated area 232 defined thereon bya plurality of ridges 234 and associated grooves 236. In addition,support member 240 has a corrugated area 242 defined thereon by aplurality of ridges 244 and associated grooves 246.

Sealing member 226 is moved from the first position (see FIG. 24) to thesecond position (see FIG. 25) by moving actuator 248 in a directionindicated by arrow 252 (see FIG. 24) until guide member 250 is no longerin contact with sealing member 226 as shown in FIG. 25. Once guidemember 250 is no longer in contact with sealing member 226, supportmember 240 spontaneously assumes its second orientation thereby liftingand supporting sealing member 226 in its second orientation (see FIG.25). Corrugated area 232 and corrugated area 242 facilitate the movementof sealing member 226 from the first orientation to the secondorientation by enhancing the flexibility of sealing member 226 andsupport member 240 in an area adjacent to sleeve 238. However, it shouldbe understood that even though the flexibility of sealing member 226 andsupport member 240 is enhanced by corrugated area 232 and corrugatedarea 242, as with sealing members 20 and sealing member 150, sealingmember 226 is held in contact with an interior surface of a body cavitywall (not shown) so as to prevent any fluid communication between anarea inside of the body cavity and an area outside of the body cavitythrough a space (not shown; see FIG. 4) defined between an opening inthe body cavity wall (not shown; see FIG. 4) and sleeve 238.

SEVENTH EMBODIMENT OF THE INVENTION

The present invention also includes a number of sealing members having abiologically active compound disposed thereon, such as an antibiotic, acytotoxic agent or a compound which effectively inhibits tumor celladherence to a membrane. As illustrated in FIG. 16, a biologicallyactive compound 166 can be disposed on the side of sealing member 150which does not engage the interior surface of the body cavity wall,referred to herein as non-contacting surface 170. However, it should beunderstood that biologically active compound 166 can also be disposedupon a contacting surface 168 (see FIG. 15) of sealing member 150 or onboth of these surfaces. Moreover, it should be appreciated thatbiologically active compound 166 can be disposed upon sleeve 148 so thatwhen it is positioned within a body cavity, biologically active compound166 is in direct contact with opening 110. It should also be understoodthat biologically active compound 166 can also be disposed upon guidemember 103. By doing so, the action of sliding guide member 103 intoopening 110 will bring the same into contact with biologically activecompound 166.

If necessary, in order to keep biologically active compound 166 fromfalling or sliding off sealing member 150 due to gravity as it is beingpositioned between the first and second orientation, biologically activecompound 166 can contain a suitable pharmaceutically acceptable carrier.A pharmaceutically acceptable carrier will also aid in retaining all, ora portion of, the biologically active compound 166 on sealing member 150as it is being advanced through an opening in a body cavity wall. Suchpharmaceutically acceptable carriers include known excipients andauxiliaries which facilitate the processing of biologically activecompound 166 into a preparation which has the appropriate consistency tobe disposed on sealing member 150.

Suitable excipients which may be used to prepare a pharmaceuticallyacceptable carrier, such as a paste, a viscous solution or a powderwhich includes fillers such as saccharides, for example lactose orsucrose, mannitol or sorbitol, cellulose preparations and/or calciumphosphates, for example tricalcium phosphate or calcium hydrogenphosphate, as well as binders such as starch paste, using, for example,maize starch, wheat starch, rice starch, potato starch, gelatintragacanth, methyl cellulose, hydroxypropylmethylcellulose, sodiumcarboxymethylcellulose, and/or polyvinyl pyrrolidone. If desired,disintegrating agents may be added such as the above-mentioned starchesand also carboxymethyl-starch, cross-linked polyvinyl pyrrolidone, agar,or alginic acid or a salt thereof, such as sodium alginate.Additionally, silica, talc, stearic acid or salts thereof such asmagnesium stearate or calcium stearate, and/or polyethylene glycol canbe used.

In addition, a suspension of biologically active compound 166 may bedisposed on sealing member 150. Suitable vehicles for such suspensionsinclude sesame oil or synthetic fatty acid esters, for example, ethyloleate or triglycerides. Such suspensions can include substances whichincrease the viscosity of the suspension including, for example, sodiumcarboxymethyl cellulose, sorbitol and/or a dextran.

The exact formulation of a pharmaceutically acceptable carrier willdepend upon the particular nature of biologically active compound 166 tobe disposed upon sealing member 150. It should also be understood thatbiologically active compound 166 can also be disposed upon the sleeve,such as sleeve 106, and the guide member, such as guide member 103.Moreover, the amount of biologically active compound 166 to dispose onsealing member 150 will depend upon the age, sex, weight, condition ofthe recipient, kind of concurrent treatment, if any, frequency oftreatment and the nature of the effect desired. However, the amount ofbiologically active compound 166 to dispose on sealing member 150 islarge enough to produce the desired effect but not so large as to causeadverse side effects, such as unwanted cross reactions, anaphylacticreactions and the like. Counterindication, if any, immune tolerance andother variables will also affect the proper amount to be disposed onsealing member 150. The exact formulation of a pharmaceuticallyacceptable carrier and the amount of biologically active compound 166contained therein (and therefore the amount disposed on sealing member150) is easily determinable by one of ordinary skill in the art fromonly routine experimentation and by applying well know principles oftherapeutics as set forth, for example, in Gilman, Alfred G. et al.,eds., The Pharmacological Basis of Therapeutics, 6th Edition, MacmillanPublishing Co., Inc. New York, N.Y. (1980) which is herein incorporatedby reference. Preferably, such preparations will contain about 0.001 toabout 99 percent biologically active compound 166 together with thepharmaceutically acceptable carrier.

A large number of antimicrobial agents (antibiotics) or antiseptics arecontemplated for use as biologically active compound 166 in the presentinvention. Preferably, where possible, the antibiotic should be activeagainst both Gram-positive and Gram negative pathogens. The followingare illustrative of the antibiotics and/or antiseptics which can bedisposed on sealing member 150 to aid in the control, inhibition orprevention of infections of the port site wound: (i) metal salts, orlike compounds with antibacterial metal ions, e.g. copper or silver, andoptionally with additional nonmetallic ions of antibacterial properties;(ii) topical antibiotics, e.g. neomycin, soframycin, bacitracin,polymcin; (iii) antibacterials such as chlorhexidine and its salts; (iv)quaternary ammonium compounds, e.g. centrimide, domiphen bromide, andpolymeric quaternaries; (v) iodophors such as povidone iodine, andpolyvinylpyrrolidoneiodine (PVP-I); (vi) acridine compounds such as9-aminoacridine, 3,6-diaminoacridine and 6,9-diamino-2-ethoxyacridine;and (vii) biguanidine compounds such as1,6-di(4-chlorophenylbiguanido)hexane, diaminohexylbiguanide,1,6-di(aminohexylbiguanido)hexane, and polyhexamethylenebiguanide.Additional suitable antibiotics include aminoglycoside antibiotics suchas amikacin, butirosin, dideoxykanamycin B (DKP), fortimycin,gentamycin, kanamycin, lividomycin, neomycin, netilmicin, ribostamycin,sagamycins, seldomycins and their epimers, sisomicin, sorbistin,tobramycin, streptomycins, linkomycins such as clindamycin, lincomycinand rifamycins such as rifampicin and rifamycin. Antibiotics such aspolymyxin B sulfate-neomycin sulfate, cleocin phosphate® (available fromthe Upjohn Company, Kalamazoo, Mich.) and erythromycin ethylsuccinateare also contemplated.

Examples of suitable antiseptics include bromchlorophen, hexetidine,buclosamide, salicylic acid, cerium nitrate, chlorhexidine,5-chloro-8-hydroxyquinoline, copper 8-hydroxyquinolate, acridine orange,undecenoic acid, undecoylium chloride and silver salts such as silversulfadiazine, mafenide, nitrofurazole, cloflucarban, tribromasalan,taurolin and noxythiolin.

With respect to aiding in the control, inhibition or prevention of tumorcell adhesion and implantation and the subsequent metastasis in the portsite wound, compounds which effectively block or inhibit tumor celladhesion (please note that tumor cell adhesion is a step in themetastasis cascade), or destroy tumor cells before adhering to eitherthe port site wound, or other sites, can be disposed on sealing member150. Types of compounds which effectively block or inhibit tumor celladherence include anticoagulants, fibrinolytic agents and compoundswhich alter the electrical charge of a membrane surface. For example,the surface charge altering and anticoagulant heparin can be disposed onsealing member 150. Additionally, any of several water-soluble highmolecular weight glucose polymers (average molecular weight (MW) 75kdal) otherwise known as dextrans, can also be disposed on sealingmember 150 to alter the surface electrical charge of nearby membranesthereby blocking tumor cell adhesion. Preferably a dextran having anaverage MW of about 40 kdal is used to coat sealing member 150.

As stated above, tumor cell destroying compounds, hereinafter referredto as cytotoxic compounds, can also be disposed on sealing member 150,with or without an acceptable pharmaceutically acceptable carrier. Thesecompounds include cisplatin, carboplatin, 5-fluorouracil,providoneiodine, tumor necrosis factor (TNF)-α, tauromustine, mitomycinC, camptothecin, bleomycin, indomethacin, N-methyl formamide, tamoxifen,sodiumhypochlorite, chlorhexidinecetrimide, adriamycin, methotrexate.Tumor cell destroying compounds also include antimetabolites such ascytarabine, azaribine, mercaptopurine, thioguanine; natural productssuch as vinblastine, vincristine, dactinomycin, daunorubicin,doxorubicin, bleomycin, mithramycin, mitomycin; and other miscellaneousagents such as cisplatin, hydroxyurea, procarbazine and mitotane,Alkylating agents such as mechlorethamine, nitrogen mustards,ethienimine derivatives, alkyl sulfonates, nitrosoureas, and triazenesare also contemplated. Moreover, the compounds disclosed by Krakoff,Irwin H. in Systemic Treatment of Cancer, CA Cancer J. Clin., vol. 46,No. 3, pages 134-141 (May/June 1996), which is incorporated herein byreference, are contemplated for being disposed on sealing member 150.

In addition antiangiogenesis agents such as angiostatin are included inthe group of cytotoxic compounds to be disposed on sealing member 150.Moreover, antibodies, including human monoclonal antibodies are includedas cytotoxic compounds. Preferably, the human monoclonal antibody HuMabSK1 as described by Chang, Helena R. et al. in Human Monoclonal AntibodySK1-Mediated Cytotoxicity Against Colon Cancer Cells, Dis. Colon Rectum,vol. 36, No.12, pages 1152-1157 (December 1993) which is incorporatedherein by reference, is disposed on sealing member 150. Other monoclonalantibodies can also be disposed on sealing member 150, for example thoseproduced from hybridomas having the accession numbers HB8573, HB8232 andHB8250 available from the American Type Culture Collection, located at12301 Parklawn Drive, Rockville Md., 20852. Furthermore, interleukin 2(IL-2), cytokines or lymphokines are also included in the group ofcytotoxic compounds of the present invention. It should also beunderstood that a combination of any of the above compounds can bedisposed on sealing member 150.

In order to apply biologically active compound 166 to sealing member150, the sealing member 150 is positioned in the second orientation (aspreviously described). Then, the biologically active compound 166 isdisposed on the sealing member 150. Thereafter, sealing member 150 isrepositioned to assume its first orientation, and then inserted throughthe opening defined in the body cavity wall as previously described.Then, the sealing member 150 is repositioned to assume its secondorientation and thereafter moved into contact with the interior surfaceof the body wall cavity. It should be understood that biologicallyactive compound 166 can be disposed on the contacting surface 168, thenon-contacting surface 170 (see FIG. 16) or on both of these surfaces.

As discussed above, depending upon the nature of biologically activecompound 166 (i.e. its ability to remain disposed on sealing member 150when placed in the second orientation and advanced through an opening ina body cavity wall), it may be mixed with a pharmaceutically acceptablecarrier prior to being disposed on sealing member 150. For example,biologically active compound 166 is suspended or dissolved in a 1%aqueous (weight/volume) solution of carboxymethylcellulose (CMC) beforebeing applied to sealing member 150 (prospective example). Such a CMCsolution provides the necessary viscosity to keep biologically activecompound 166 from sliding or rolling off sealing member 150 when it isin the first position and being advanced through an opening in a bodycavity wall.

Once located in the body cavity and in contact with an interior surfacethereof, biologically active compound 166 establishes a "pharmacologicalbarrier" between the interior of the body cavity and the opening in thebody cavity wall. This "pharmacological barrier" helps prevent tumorcell implantation in the port site wound and/or the contamination of theport site wound with viable infectious microbes.

EIGHTH EMBODIMENT OF THE INVENTION

Now referring to FIGS. 34-37, there is shown a cannula 302 advancedthrough an opening 322 in a wall 320 of a body cavity 324. Cannula 302includes a plurality of sealing members 304, 306, 308, and 310 attachedto exterior surface 312 of cannula 302. Sealing members 304, 306, 308,and 310 are attached to exterior surface 312 such that sealing members304, 306, 308, and 310 are spaced apart from each other along alongitudinal axis 330 of cannula 302. Each sealing member 304, 306, 308,and 310 defines a fluid impervious bladder for receiving a fluid, suchas air. Other types of sealing members are also contemplated, forexample a number of disks which are spaced apart from each other alonglongitudinal axis 330 of cannula 302. Cannula 302 also includes a numberof valves 314, 316, and 318 attached to exterior surface 312 of cannula302. Cannula 302 also includes a fourth valve (not shown) attached toexterior surface 312. The fourth valve is identical to valves 314, 316,and 318 but is attached to exterior surface 312 on the opposite side ofcannula 302 as compared to valve 316. Valves 314, 316, 318, and thefourth valve can be any of a number of well known valves capable ofmaintaining and then releasing a fluid under pressure (e.g. a trumpetvalve).

Each valve 314, 316, 318, and the fourth valve is in fluid communicationwith one sealing member 304, 306, 308, or 310. Specifically, valve 314is in fluid communication with sealing member 310 via a channel (notshown) defined in cannula 302. Valve 316 is in fluid communication withsealing member 308 via another channel (not shown) defined in cannula302. Valve 318 is in fluid communication with sealing member 306 viaanother channel (not shown) defined in cannula 302. The fourth valve isin fluid communication with sealing member 304 via another channel (notshown) defined in cannula 302. It should be understood that the abovediscussed channels are identical to and function in substantially thesame manner as channel 195 as described in reference to sleeve 168 (seeFIGS. 19-22). Therefore, it should be appreciated that the channelsdefined in cannula 302 allow a fluid, such as air, to be advanced intoand withdrawn from each fluid impervious bladder defined by sealingmember 304, 306, 308, and 310.

As shown in FIGS. 35, 36, and 37, valves 314, 316, and 318 are connectedto a valve 334 via hoses 328, 336, and 338, respectively. The fourthvalve is also connect to valve 334 via a hose (not shown). Valve 334 isconnected to an air supply S via hose 340. Valve 334 is any well knownvalve capable of selectively directing an air flow delivered by airsupply S to one or more of hoses 328, 336, 338 and the fourth hose. Airsupply S can be manually operated (e.g. a syringe) or power driven (e.g.an air compressor).

It should be appreciated that the above described arrangement allows asurgeon to selectively place one or more of sealing member 304, 306,308, and 310 in fluid communication with air supply S. For example,valve 334 can be adjusted such that only sealing member 310 is in fluidcommunication with air supply S. When valve 334 is placed in thisconfiguration, an air flow generated by actuating air supply S will bedirected in the following manner as illustrated by arrows 342 (see FIG.35) from air supply S through hose 340, valve 334, hose 328, valve 314,the channel defined in cannula 302, and into the fluid imperviousbladder defined by sealing member 310. Once the air flow enters thefluid impervious bag defined by sealing member 310, sealing member 310inflates to form an annular disk (i.e. the second orientation forsealing member 310) as shown in FIG. 35. Sealing member 310 is deflatedby releasing the air trapped in sealing member 310 through valve 314.Releasing air through valve 314 causes sealing member 310 to assume itspre-inflation configuration (i.e. the first orientation for sealingmember 310) as shown in FIG. 34.

It should be appreciated that sealing members 308, 306, and 304 areinflated and deflated in substantially the same manner. For example,sealing member 308 is inflated by adjusting valve 334 such that airsupply S is in fluid communication with hose 336 and then advancing anair flow through hose 336, valve 316 the channel defined in cannula 302,and into the fluid impervious bag defined by sealing member 308. Oncethe air flow enters the fluid impervious bag defined by sealing member308, sealing member 308 inflates to form an annular disk as shown inFIG. 36. Sealing member 308 is deflated by releasing the air trapped insealing member 308 through valve 316. Releasing air through valve 316causes sealing member 308 to assume its pre-inflation configuration asshown in FIG. 34.

When performing a medical procedure, such as laparoscopic surgery,cannula 302 can be substituted for the combination of sleeve 18 andcannula 14 which are described above in reference to the firstembodiment of the invention. In addition, cannula 302 is used in asimilar way as that described above for the combination of sleeve 18 andcannula 14. Specifically, a trocar (not shown) is positioned within thelumen (not shown) of cannula 302. The trocar is then placed in contactwith, and advanced through, body cavity wall 320 to create opening 322(see FIG. 34). Preferably, cannula 302 and the trocar are simultaneouslyadvanced through opening 322 and into body cavity 324, and as shown inFIG. 35, once cannula 302 is located within opening 322, sealing member310 is inflated and cannula 302 is positioned such that sealing member310 contacts an interior surface 326 of body cavity wall 320. Havingsealing member 310 in contact with interior surface 326 prevents fluidcommunication between an area inside of body cavity 324 and an areaoutside of body cavity 324 through a space 344 defined between opening322 in body cavity wall 320 and cannula 302. The trocar is thencompletely removed from the lumen of cannula 302 such that the lumenprovides an access into body cavity 324.

Referring now to FIG. 36, sealing member 310 can be deflated and cannula302 moved in a direction indicated by arrow 332 so as to further advancecannula 302 into body cavity 324. Once cannula 302 is repositioned inthe above described manner, sealing member 308 is inflated andpositioned in contact with interior surface 326 of body cavity wall 320.Having sealing member 308 in contact with interior surface 326 preventsfluid communication between an area inside of body cavity 324 and anarea outside of body cavity 324 through space 344 defined betweenopening 322 in body cavity wall 320 and cannula 302. Cannula 302 canalso be positioned relative to opening 322 such that sealing members 306or 304 can be inflated and positioned in contact with interior surface326 and thus prevent fluid communication between an area inside of bodycavity 324 and an area outside of body cavity 324 through space 344defined between opening 322 in body cavity wall 320 and cannula 302.Being able to locate cannula 302 relative to opening 322 in theaforementioned positions and still prevent the above described fluidcommunication is an important aspect of the present invention.Specifically, being able to move cannula 302 in the above describedmanner provides a surgeon with added flexibility in positioning cannula302 within body cavity 324 (and therefore any medical instrumentsinserted into body cavity 324 via cannula 302) while protecting opening322 from contamination with cancerous or infectious cells. Thus, havingsealing members 304, 306, 308, and 310 attached to exterior surface 312of cannula 302 in the above described manner enhances the surgeon'sability to successfully complete the surgery while protecting opening322 from contamination with cancerous or infectious cells.

As shown in FIG. 37, two sealing members (e.g. sealing members 304 and308) can be inflated simultaneously and positioned relative to bodycavity wall 320 such that body cavity wall 320 is interposed between thetwo inflated sealing members. Having body cavity wall 320 interposedbetween two inflated sealing members stabilizes sleeve 302 in opening322 and prevents any uncontrolled loss of the pneumoperitoneum.

After completing the medical procedure utilizing cannula 302, anymedical instruments and/or specimens positioned within body cavity 324are withdrawn therefrom through the lumen of cannula 302. Insufflationgas is then allowed to rapidly escape from body cavity 324 through thelumen of cannula 302.

Once substantially all the insufflation gas has escaped from body cavity324 (i.e. body cavity 324 has been desufflated) sealing members 304,306, 308, and 310 are all deflated, thereby facilitating the removal ofcannula 302 from opening 322.

Thus, it should be understood that cannula 302 including sealing members304, 306, 308, and 310 are the last components to be removed from bodycavity 324 by the surgeon (not shown). Removing cannula 302 includingsealing members 304, 306, 308, and 310 last ensures that opening 322(i.e. the port site wound) remains protected against tumor cellimplantation or contamination with an infectious agent in the samemanner as described above in reference to sleeve 18.

CONCLUSION

Based upon the above description it will be understood by those skilledin the art that the present invention provides a medical apparatus forprotecting a port site wound which adds only a minimal amount of bulk tothe diameter of a trocar assembly. In addition, it will be understood bythose skilled in the art that the present invention provides a medicalapparatus for continuous protection of a port site wound which enablesthe independent movement of a cannula or trocar assembly, thus allowingthe surgeon to functionally utilize the cannula and instruments to theirfullest design. Moreover, it will be understood by those skilled in theart that the medical apparatus of the present invention can be retrofitto existing trocar assembly technology. Furthermore, the medicalapparatus of the present invention allows minimally invasive surgicaltechniques, such as laparoscopic surgery, to be safely applied to cancersurgery. In addition, the medical apparatus of the present inventionserves as a platform upon which additional technology (e.g. sensors orvisual platforms) may be placed inside the abdomen and used inconjunction with laparoscopic surgery.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, such illustration and description isto be considered as exemplary and not restrictive in character, it beingunderstood that only the preferred embodiments have been shown anddescribed and that all changes and modifications that come within thespirit of the invention are desired to be protected. For example, whilethe mechanism described above for moving the sealing members from thefirst orientation to the second orientation has many benefits, othermechanisms may be used. One such mechanism may utilize pressure in thebody cavity to force the sealing members against the interior surfacethereof. Additional mechanisms which can be used to move the sealingmembers include the use of pistons attached to the sealing members,cords attached to the sealing members and a screw mechanism foractuating the sealing members. Furthermore, a system of tubes integratedin the sleeve can be used to deliver the biologically active compound tothe sealing members via capillary action. Moreover, a sponge likematerial having a biologically active compound disposed thereon can beattached to the sleeves or cannula of the present invention such thatwhen the sleeve or cannula is positioned within a port site wound thesponge like material and therefore the biologically active compoundcomes into contact with a sidewall of the port site wound so as toprevent viable cells from being implanted therein. Additionally, othermaterials are contemplated for use in making the sealing member. Forexample, a cannula or sleeve utilizing thin, overlapping, filamentousbristles which create a pliable sealing member are contemplated. Inaddition, a material such as a sponge can be used to create a sealingmember, particularly if the sponge material has any of the abovedescribed biologically active compounds disposed thereon. Moreover,foam, or other materials which are capable of altering their degree ofpliability and serve as sealing members are contemplated. In addition,the beads may also have electric or magnetic characteristics whichfacilitates the conversion of the sealing members from their soft,pliable state, to their stable rigid state.

What is claimed is:
 1. A medical apparatus positionable within an opening in a wall of a body cavity, comprising:a trocar assembly including a cannula and a trocar, wherein (1) said cannula has a lumen defined therein, (2) said trocar is positionable between a first trocar position and a second trocar position, (3) said trocar is positioned within said lumen of said cannula when said trocar is positioned at said first trocar position, and (4) said trocar is completely removed from said lumen of said cannula when said trocar is positioned at said second trocar position; a sleeve having a passageway extending therethrough, and a number of sealing members extending therefrom, wherein (1) said cannula is positionable between a first cannula position and a second cannula position, (2) said cannula is positioned within said passageway of said sleeve when said cannula is positioned at said first cannula position, and (3) said cannula is completely removed from said passageway of said sleeve when said cannula is positioned at said second cannula position; and an actuator secured to said sealing members and having a chamber defined therein, said actuator further defining a port through which fluid may be advanced into or withdrawn from said chamber, wherein said sealing members are movable between a first orientation and a second orientation when said cannula is positioned within said passageway of said sleeve, wherein said sealing members are positioned in said first orientation during creation of said opening in said body wall, and wherein said sealing members are in contact with an interior surface of said wall of said body cavity when said sealing members are positioned in said second orientation.
 2. The medical apparatus of claim 1, further comprising:a vacuum source or an air supply in fluid communication with said port of said actuator.
 3. The medical apparatus of claim 2, wherein:said sealing members are positioned in said first orientation when said sealing members are positioned in a substantially parallel relationship with said passageway, said sealing members are positioned in said second orientation when said sealing members are positioned substantially perpendicular to said passageway, said sealing members are moved to said first orientation in response to fluid being advanced into said chamber, and said sealing members are moved to said second orientation in response to fluid being evacuated from said chamber.
 4. The medical apparatus of claim 3, further comprising a channel defined in said sleeve, wherein:said channel is in fluid communication with said chamber of said actuator and said vacuum source or said air supply.
 5. A medical apparatus, comprising:a trocar assembly including a cannula and a trocar, wherein (1) said cannula has a lumen defined therein, (2) said trocar is positionable between a first trocar position and a second trocar position, (3) said trocar is positioned within said lumen of said cannula when said trocar is positioned at said first trocar position, and (4) said trocar is completely removed from said lumen of said cannula when said trocar is positioned at said second trocar position; a sleeve having a passageway extending therethrough, and a number of sealing members extending therefrom, wherein (1) said cannula is positionable between a first cannula position and a second cannula position, (2) said cannula is positioned within said passageway of said sleeve when said cannula is positioned at said first cannula position, and (3) said cannula is completely removed from said passageway of said sleeve when said cannula is positioned at said second cannula position; an actuator secured to said sealing members and having a chamber defined therein, said actuator further defining a port through which fluid may be advanced into or withdrawn from said chamber; a vacuum source or an air supply in fluid communication with said port of said actuator, wherein said sealing members are movable between (1) a first orientation in which said sealing members are positioned in a substantially parallel relationship with said passageway, and (2) a second orientation in which said sealing members are positioned substantially perpendicular to said passageway, wherein said sealing members are moved to said first orientation in response to fluid being advanced into said chamber, wherein said sealing members are moved to said second orientation in response to fluid being evacuated from said chamber, and wherein said number of sealing members include a first sealing member and a second sealing member, further comprising a web connected between said first sealing member and said second sealing member.
 6. A medical apparatus, comprising:a trocar assembly including a cannula and a trocar, wherein (1) said cannula has a lumen defined therein, (2) said trocar is positionable between a first trocar position and a second trocar position, (3) said trocar is positioned within said lumen of said cannula when said trocar is positioned at said first trocar position, and (4) said trocar is completely removed from said lumen of said cannula when said trocar is positioned at said second trocar position; a sleeve having a passageway extending therethrough, and a number of sealing members extending therefrom, wherein (1) said cannula is positionable between a first cannula position and a second cannula position, (2) said cannula is positioned within said passageway of said sleeve when said cannula is positioned at said first cannula position, and (3) said cannula is completely removed from said passageway of said sleeve when said cannula is positioned at said second cannula position; an actuator secured to said sealing members and having a chamber defined therein, said actuator further defining a port through which fluid may be advanced into or withdrawn from said chamber; a vacuum source or an air supply in fluid communication with said port of said actuator; and a channel defined in said sleeve, wherein said sealing members are movable between (1) a first orientation in which said sealing members are positioned in a substantially parallel relationship with said passageway, and (2) a second orientation in which said sealing members are positioned substantially perpendicular to said passageway, wherein said sealing members are moved to said first orientation in response to fluid being advanced into said chamber, wherein said sealing members are moved to said second orientation in response to fluid being evacuated from said chamber, wherein said channel is in fluid communication with said chamber of said actuator and said vacuum source or said air supply, wherein said actuator includes (1) a first wall segment attached to said sleeve, (2) a second wall segment attached to said sealing members, and (3) a flexible cover attached to said first wall segment and said second wall segment, and wherein said second wall segment is movable relative to said first wall segment.
 7. The medical apparatus of claim 6, wherein evacuation of air from said chamber causes said second wall segment to move toward said first wall segment.
 8. A medical apparatus comprising:a sleeve having a number of sealing members connected thereto and a passageway extending therethrough, said sealing members being movable between (1) a first orientation in which said sealing members are positioned to facilitate advancement of said sleeve into an opening defined in a wall of a body cavity, and (2) a second orientation in which said sealing members are positioned to prevent fluid communication between an area inside of the body cavity and an area outside of the body cavity through a space defined between the opening in the wall of the body cavity and said sleeve; a trocar assembly positionable within said passageway of said sleeve, said trocar assembly including a cannula and a trocar, wherein (1) said cannula is completely removable from said passageway of said sleeve, (2) said cannula has a lumen defined therein, and (3) said trocar is completely removable from said lumen of said cannula; and an actuator secured to said sealing members and having a chamber defined therein, said actuator further defining a port through which fluid may be advanced into or withdrawn from said chamber, wherein said sealing members are movable between said first orientation and said second orientation when said cannula is positioned within said passageway of said sleeve, wherein said sealing members are positioned in said first orientation during creation of said opening in said body wall, and wherein said sealing members are in contact with an interior surface of said wall of said body cavity when said sealing members are positioned in said second orientation.
 9. The medical apparatus of claim 8, further comprising:a vacuum source or an air supply in fluid communication with said port of said actuator.
 10. The medical apparatus of claim 9, further comprising a channel defined in said sleeve, wherein:said channel is in fluid communication with said chamber of said actuator and said vacuum source or said air supply.
 11. The medical apparatus of claim 8, wherein:said sealing members are moved to said first orientation in response to fluid being advanced into said chamber, and said sealing members are moved to said second orientation in response to fluid being evacuated from said chamber.
 12. A medical apparatus, comprising:a sleeve having a number of sealing members connected thereto and a passageway extending therethrough, said sealing members being movable between (1) a first orientation in which said sealing members are positioned to facilitate advancement of said sleeve into an opening defined in a wall of a body cavity, and (2) a second orientation in which said sealing members are positioned to prevent fluid communication between an area inside of the body cavity and an area outside of the body cavity through a space defined between the opening in the wall of the body cavity and said sleeve; a trocar assembly positionable within said passageway of said sleeve, said trocar assembly including a cannula and a trocar, wherein (1) said cannula is completely removable from said passageway of said sleeve, (2) said cannula has a lumen defined therein, and (3) said trocar is completely removable from said lumen of said cannula; and an actuator secured to said sealing members and having a chamber defined therein, said actuator further defining a port through which fluid may be advanced into or withdrawn from said chamber, wherein said number of sealing members include a first sealing member and a second sealing member, further comprising a web member connected between said first sealing member and said second sealing member.
 13. A medical apparatus, comprising:a sleeve having a number of sealing members connected thereto and a passageway extending therethrough, said sealing members being movable between (1) a first orientation in which said sealing members are positioned to facilitate advancement of said sleeve into an opening defined in a wall of a body cavity, and (2) a second orientation in which said sealing members are positioned to prevent fluid communication between an area inside of the body cavity and an area outside of the body cavity through a space defined between the opening in the wall of the body cavity and said sleeve; a trocar assembly positionable within said passageway of said sleeve, said trocar assembly including a cannula and a trocar, wherein (1) said cannula is completely removable from said passageway of said sleeve, (2) said cannula has a lumen defined therein, and (3) said trocar is completely removable from said lumen of said cannula; and an actuator secured to said sealing members and having a chamber defined therein, said actuator further defining a port through which fluid may be advanced into or withdrawn from said chamber, wherein said sealing members are moved to said first orientation in response to fluid being advanced into said chamber, wherein said sealing members are moved to said second orientation in response to fluid being evacuated from said chamber, wherein said actuator includes (1) a first wall segment attached to said sleeve, (2) a second wall segment attached to said sealing members, and (3) a flexible cover attached to said first wall segment and said second wall segment, and wherein said second wall segment is movable relative to said first wall segment.
 14. The medical apparatus of claim 13, wherein evacuation of air from said chamber causes said second wall segment and said first wall segment to move relative to each other.
 15. A medical procedure, comprising the steps of:creating an opening in a wall of a body cavity; advancing a medical apparatus through the opening and into the body cavity, said medical apparatus including (1) a sleeve having a number of sealing members connected thereto and a passageway extending therethrough, (2) a trocar assembly positioned within the passageway of said sleeve, said trocar assembly including a cannula and a trocar, wherein (a) said cannula is completely removable from said passageway of said sleeve, (b) said cannula has a lumen defined therein, and (c) said trocar is completely removable from said lumen of said cannula, and (3) an actuator having a chamber defined therein, said actuator further defining a port through which fluid may be advanced into or withdrawn from said chamber; evacuating fluid from said chamber of said actuator so that said sealing members are positioned substantially perpendicular to said passageway; and positioning said sealing members to contact an interior surface of said body cavity after said fluid evacuation step.
 16. The medical procedure of claim 15, further comprising the steps of:advancing fluid into said chamber of said actuator so that said sealing members are positioned substantially parallel to said passageway; and removing said medical apparatus from the opening in the wall of the body cavity.
 17. The medical procedure of claim 15, wherein said advancing step includes the step of simultaneously advancing said sleeve and said trocar assembly through the opening and into the body cavity.
 18. The medical procedure of claim 15, wherein said advancing step includes the step of introducing fluid into said chamber of said actuator so that said sealing members are positioned substantially parallel to said passageway whereby advancement of the sleeve through the opening and into the body cavity is facilitated.
 19. The medical procedure of claim 15, wherein:said number of sealing members include a first sealing member and a second sealing member; and a web is connected between said first sealing member and said second sealing member.
 20. The medical apparatus of claim 15, further comprising a channel defined in said sleeve, wherein:said channel is in fluid communication with said chamber of said actuator and a vacuum source or an air supply. 